Regulatory Specialist

• Mar 2017 - Present

Responsibilities include management of IRB-related tasks, (including all submissions, approvals, correspondence, and more, at both a central and site level), creation and maintenance of all Investigator Site Files from study start to study completion, and management of study archival and record keeping for all completed studies.

Coordinator, Clinical Project Services

• Dec 2015 - Mar 2017

Responsible solely for the creation and maintenance of all clinical trial source documents. Responsibilities included protocol review, and coordination with multiple departments (Clinical Operations, Nutrition, Data Management, Laboratory, Quality Control) to produce final, high-quality source documents.

Clinical Project Manager

• Dec 2014 - Dec 2015

Clinical Project Manager

• Apr 2013 - Aug 2014

Managed all administrative and operational aspects of a clinical trial from study planning to close out (Phase I, IIa, device). Identified and selected third party vendors for outsourced services. Managed study regulatory submission and reporting to central and local IRBs. Oversight of training compliance of specific protocol related items for the following departments: screening, recruiting, pharmaceutical services, and clinical operations. Reviewed protocol and designed study specific source documents and subject information hand-outs for designated studies. Oversight of all study specific volunteer recruitment activities, including review and placement of study specific advertisements. Reviewed client protocols and case report forms for study related logistical issues. Responsible for updating study tracking tools including study information files. Responsible for the transcription of study data from source documents to paper or electronic case report forms. Performed verification and resolution of data discrepancies in a timely manner. Assisted in reviewing source books for accuracy and completeness with attention to GCP guidelines and company SOPs. Participated with questioning and recording subject’s adverse events/serious adverse events during study, and providing this information in regular safety updates to the Sponsor. Show less

Associate Clinical Project Manager

• Jul 2012 - Apr 2013

Clinical Project Manager Assistant

• Sep 2010 - Jul 2012